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    Summary
    EudraCT Number:2013-001304-11
    Sponsor's Protocol Code Number:ACDHUVV-13
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-08-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-001304-11
    A.3Full title of the trial
    Evaluation of myocardial and clinical beneficial effect of sevoflurane in intraoperative and postoperative myocardial revascularization surgery, compared with propofol

    Evaluación del efecto beneficioso miocárdico y clínico del sevoflurano, en el intraoperatorio y postoperatorio de cirugía de revascularización miocárdica en comparación con el propofol
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessing the potential benefit of the use of sevoflurane as an anesthetic during bypass surgery and subsequent recovery
    Evaluación del posible efecto beneficioso del uso de sevoflurano como anestésico durante cirugía de revascularización y en la recuperación posterior
    A.4.1Sponsor's protocol code numberACDHUVV-13
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAsociación Andaluza-Extremeña de Anestesiología, Reanimación y Terapéutica del Dolor
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
    B.5.2Functional name of contact pointProyect Manager
    B.5.3 Address:
    B.5.3.1Street AddressAv. Jorge Luis Borges nº15 Bl.3 Pl.3
    B.5.3.2Town/ cityMálaga
    B.5.3.3Post code29010
    B.5.3.4CountrySpain
    B.5.4Telephone number0034951440260
    B.5.5Fax number0034951440263
    B.5.6E-mailpatricia.vergara@fundacionimabis.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name SEVORANE
    D.2.1.1.2Name of the Marketing Authorisation holderAbbvie Farmaceutica, S.L.U.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSevoflurane
    D.3.4Pharmaceutical form Inhalation vapour, liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSevoflurane
    D.3.9.1CAS number 28523-86-6
    D.3.9.3Other descriptive nameSEVOFLURANE
    D.3.9.4EV Substance CodeSUB10506MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Propofol Lipomed Fresenius
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePropofol
    D.3.4Pharmaceutical form Emulsion for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPropofol
    D.3.9.3Other descriptive namePROPOFOL
    D.3.9.4EV Substance CodeSUB10116MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.2 to 2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Assessment of the beneficial effects of sevoflurane during the intraoperative and immediate postoperative myocardial revascularization surgery. Assessment will be through biochemical markers of myocardial injury and dysfunction
    Evaluación de los efectos beneficiosos del sevoflurano, en el intraoperatorio y postoperatorio inmediato de cirugía de revascularización miocárdica. La evaluación se hará a través de marcadores bioquímicos de lesión y disfunción miocárdica
    E.1.1.1Medical condition in easily understood language
    To evaluate the protective effect on the heart function of the use of sevoflurane as a hypnotic in this surgery
    Evaluar el efecto protector sobre la función del corazón del uso del sevoflurano como hipnótico en esta cirugía
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effects of sevoflurane on intra-and postoperative patients undergoing myocardial revascularization surgery compared to propofol in terms of harm reduction and myocardial injury
    Evaluar los efectos de la administración de sevoflurano en el intra y postoperatorio de los pacientes intervenidos de cirugía de revascularización miocárdica respecto al propofol en cuanto a disminución del daño y lesión miocárdica
    E.2.2Secondary objectives of the trial
    Knowledge of the mechanisms by which myocardial protection occurs in both intraoperatively and postoperatively, determining which of the different effector pathways of preconditioning and postconditioning

    Determine length of stay in the intensive care unit of each of the groups to determine if the potentiation of the effect through the postoperative administration, reduces per se the stay in the intensive care unit

    Identify differences in rhythm disorder episodes (tachyarrhythmias), thanks mainly to the effects of postconditioning, and the biochemical basis of this beneficial effect
    Conocimiento de los mecanismos por los cuales se produce la protección miocárdica, tanto en el intraoperatorio como en el postoperatorio, determinando cual de las distintas rutas efectoras del precondicionamiento y postcondicionamiento

    Determinar días de estancia en la unidad de cuidados intensivos de cada uno de los grupos, para conocer si la potenciación del efecto a través de la administración en el postoperatorio inmediato, disminuye per se la estancia en la unidad de cuidados intensivos

    Identificar diferencias en episodios de trastorno de ritmo (taquiarritmias), gracias principalmente a los efectos del postcondicionamiento, y las bases bioquímicas de este efecto beneficioso
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Elective off-pump CABG.
    2.EUROSCORE (European level of risk, useful in the perioperative period of cardiac surgery patients, validated medical and scientific level) under 8 (moderate risk in the perioperative cardiac).
    3. Anesthetic risk level according to the American Society of Anesthesia (ASA) of less than 4 (moderate anesthetic risk patient-high).
    1. Cirugía electiva de revascularización miocárdica sin bomba.
    2.EUROSCORE (escala europea de riesgo, útil en el perioperatorio de los pacientes intervenidos de cirugía cardiaca, validada a nivel médico y científico) menor de 8 (riesgo moderado cardiológico en el perioperatorio).
    3. Grado de riesgo anestésico según la sociedad americana de anestesia (ASA) menor de 4 ( paciente de riesgo anestésico moderado-alto).
    E.4Principal exclusion criteria
    1. History of adverse reaction to the various anesthetic drugs.
    2. Severe disease of any organ (lung, liver, kidney), diagnosed preoperatively.
    3. Combined surgery (eg valve repair or carotid surgery).
    4. Patients in hemodynamic instability.
    5. Heart failure or need for use of inotropes or vasoactive before surgery.
    6. Treatment with oral antidiabetics suspended at least 48 hours before.
    7. Treatment eufilina / theophylline before surgery.
    1. Historia de reacción adversa a los distintos fármacos anestésicos.
    2. Enfermedad severa de cualquier órgano (pulmón, hígado, riñón), diagnostica de manera preoperatoria.
    3. Cirugía combinada (ejemplo reparación valvular o de cirugía carotidea).
    4. Pacientes en situación de inestabilidad hemodinámica.
    5. Insuficiencia cardiaca o necesidad de uso de fármacos inotrópicos o vasoactivos previos a la intervención.
    6. Tratamiento con antidiabéticos orales no suspendido al menos 48 horas antes.
    7. Tratamiento con eufilina/teofilina previo a la intervención.
    E.5 End points
    E.5.1Primary end point(s)
    Damage and myocardial injury (NT-proBNP levels, troponinaI, CK and CKMMB)
    Daño y lesión miocárdica ( niveles de NT-ProBNP, troponinaI, CK y CKMMB)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Discharge Report of intensive care unit
    Registro de alta de la unidad de cuidados intensivos
    E.5.2Secondary end point(s)
    Cardiac rhythm disorder episodes
    Days of stay in the intensive care unit
    Episodios de trastorno de ritmo cardiaco
    Días de estancia en la unidad de cuidados intensivos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Discharge Report of intensive care unit
    Registro de alta de la unidad de cuidados intensivos
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-20
    P. End of Trial
    P.End of Trial StatusOngoing
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